In treating a bone fracture it is common practice to fasten one bone segment to the other so as to stabilize and immobilize them for the duration of the bone consolidation process. Thus there is the technique of internal fixation or direct mechanical fastening of the bone segments.
Traditionally, fixation has been accomplished by variety of apparatus and techniques, the more common involving the use of metallic fastening devices such as screws, connector plates (secured to the bone by screws), pins and clips. These methods invariably involve the drilling of screw holes in the bone and the use of related equipment such as drill hole templates.
Conventional U-shaped clips have also been used, the clip legs being installed one each in holes in the opposing bone segments. The rigid structure of such clips, like the other fixation devices mentioned above, provides rigid immobilization of the fracture zone. Such devices also serve to maintain the distance between segments. However, among other things, such distance hinders compression induced by contractions of skeletal muscles in some cases, and prevents the establishment of compressive force between the bone segments which is favorable to bone consolidation or knitting. In this regard the concept of creating dynamic compressive force across an osteotomy or bone fracture site has become recognized as a technique to promote primary bone healing, i.e. consolidation that is faster and of better quality.
Thus there has evolved a number of fastening devices such as clips and the like, designed to deliver compression. Accordingly in U.S. Pat. No. 3,939,294 there is provided a clasp or clip of spring material having a pair of spaced-apart, inwardly inclined legs connected by a Z-shaped upper portion. Sloped holes are drilled in adjoining bone segments and tools are used to manipulate and install one leg, and then the other leg is pulled toward the other hole, spreading the Z-shaped elastic portion, and then inserted in the other hole. Unfortunately this method requires the drilling of specially sloped holes, involves multiple steps and is time-consuming, and like the conventional rigid fastening techniques, requires relatively large surgical opening. Also, the manual installation of the clip using hemostats and the like is difficult, requires meticulous skill and handling.
In U.S. Pat. No. 4,838,254, the legs of a pair of metallic clips are inserted in pairs of specially angled bores in respective opposing bone segments. The exposed tops of the two installed clips then serve as fastening heads for a spring that is connected between the clips.
In U.S. Pat. No. 4,841,960 the disclosed compression clip is essentially a clip with opposing legs that are installed in pre-drilled holes and features a crimpable web that joins the top ends of the legs. A crimping tool is used to crimp the web in an effort to set up compression between the embedded legs.
U.S. Pat. No. 4,852,558 also requires manual installation of separate legs in pre-drilled holes, the tops of the install legs then being interconnected with a ratchet mechanism which must be operated to draw the legs together. This design appears inherently limited regarding adjustability and maintenance of constant pressure. In U.S. Pat. No. 5,660,188 the two legs of a clip must also be installed in pre-drilled holes. The clip has a bridge of two side-by-side crimpable elements, and the jaws of a crimping tool must be used on the embedded clip to deformingly spread apart these elements, causing the legs to draw to each other. The foregoing techniques involving crimpable clips all appear to be imprecise in setting up suitable compressive forces, require hole drilling and related problems, and do not lend themselves to minimizing the size of the surgical opening.
In view of the limitations of the afore-mentioned methods, stapling has been looked to as a way to produce compression. Thus in U.S. Pat. Nos. 5,053,038 and 5,662,655, staples are applied to the bone by a powered stapler. However, there is little apparent precision in establishing the desired compressive forces.
Thus, there remains a need for bone staples for achieving compression between segments.